Transcutaneous Tibial Nerve Stimulation for Treating Neurogenic Lower Urinary Tract Dysfunction

NCT ID: NCT02859844

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-03-31

Brief Summary

Many patients with neurological diseases suffer from neurogenic lower urinary tract dysfunction (NLUTD), which often severely impairs quality of life, due to urinary urgency with or without incontinence and voiding dysfunction. In addition, the upper urinary tract may be jeopardized because of high intravesical pressure caused by detrusor overactivity with concurrent detrusor-sphincter-dyssynergia and/or low bladder compliance. The treatment of NLUTD is a challenge since conventional conservative therapies often fail and more invasive treatments such as intradetrusor onabotulinumtoxinA injections, bladder augmentation and urinary diversion have to be considered. Neuromodulation therapies including tibial nerve stimulation (TNS) may be alternative non-invasive treatment options. Indeed, TNS is an effective and safe treatment for idiopathic overactive bladder proven in randomized controlled trials (RCTs), but its value in neurological patients is unclear. In a recent systematic review, the investigators found evidence that TNS might become a promising treatment option for NLUTD, however, more reliable data from well-designed RCTs are urgently needed to reach definitive conclusions. However, the investigators study will be the first adequately sampled and powered, randomized, placebo-controlled, double-blind trial assessing transcutaneous TNS (TTNS) for NLUTD. This trial will provide significant insights into the efficacy of TTNS in patients suffering from NLUTD and in the case that this treatment is really effective in the neurological population, the investigators findings would completely revolutionize the management of NLUTD in daily clinical practice. Moreover, this interdisciplinary trial will relevantly influence the neurological and urological approach in the management of NLUTD promoting future collaborative projects improving patients' medical care and underlying the pioneering role of Switzerland in the rapidly developing and ambitious research field of neuro-urology.

Conditions

Neurogenic Bladder Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TTNS ON

Transcutaneous tibial nerve stimulation

Group Type: EXPERIMENTAL

Transcutaneous Tibial Nerve Stimulation (TTNS)

Intervention Type: DEVICE

TTNS OFF

Sham/placebo stimulation

Group Type: SHAM_COMPARATOR

Transcutaneous Tibial Nerve Stimulation (TTNS)

Intervention Type: DEVICE

Interventions

Transcutaneous Tibial Nerve Stimulation (TTNS)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Refractory LUTD due to a neurological disorder:
• Urgency frequency syndrome and/or urgency incontinence refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics)
• Chronic urinary retention refractory to alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
• Combination of urgency frequency syndrome and/or urgency incontinence and chronic urinary retention refractory to antimuscarinics (pharmacotherapy for at least 4 weeks with at least 2 antimuscarinics) and alpha-blocker (pharmacotherapy with an alpha-blocker for at least 4 weeks)
• Age >18 years
• Informed consent

Exclusion Criteria

• Botulinum A toxin injections in the detrusor and/or urethral sphincter in the last 6 months
• Age <18 years
• Pregnancy
• Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences www.samw.ch/en/News/News.html)
• No informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

EOC-Ospedale regional Bellinzona e Valli

Bellinzona, , Switzerland

Universitätsklinik Balgrist

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

2016-01016

Identifier Type: -

Identifier Source: org_study_id